NCT02176421 is a NA clinical trial of VOLBELLA® with lidocaine in Infra-orbital Skin Depressions, sponsored by Allergan.

Who is sponsoring NCT02176421?

NCT02176421 is sponsored by Allergan.

What drugs are being tested in NCT02176421?

Interventions in NCT02176421: VOLBELLA® with lidocaine.

What condition does NCT02176421 study?

NCT02176421 studies Infra-orbital Skin Depressions.

Is NCT02176421 still recruiting?

NCT02176421 is currently completed. Last updated 16 April 2019.

Are results published for NCT02176421?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-16 · How we verify

NCT02176421

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area

Completed NA Results posted Last updated 16 April 2019

What this trial tests

NA trial testing VOLBELLA® with lidocaine in Infra-orbital Skin Depressions in 80 participants. Completed in 3 July 2015.

Timeline

15 May 2014

Primary endpoint
18 August 2014

3 July 2015

Quick facts

Lead sponsor	Allergan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	15 May 2014
Primary completion	18 August 2014
Estimated completion	3 July 2015
Sites	1 location across France

Drugs / interventions tested

VOLBELLA® with lidocaine

Conditions studied

Infra-orbital Skin Depressions — all drugs for Infra-orbital Skin Depressions →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Infra-orbital Skin Depressions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side Primary · Baseline, Month 1

The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).

Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	99

Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	100

Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side Secondary · Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12

The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).

Day 0 Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	99

Day 0 Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	99

Day 14 Right Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	98

Day 14 Left Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	100

Month 6 Right Side (N=73)

Group	Value	95% CI
VOLBELLA® With Lidocaine	93

Month 6 Left Side (N=73)

Group	Value	95% CI
VOLBELLA® With Lidocaine	92

Month 9 Right Side (N=72)

Group	Value	95% CI
VOLBELLA® With Lidocaine	81

Month 9 Left Side (N=72)

Group	Value	95% CI
VOLBELLA® With Lidocaine	83

Injector Ease of Use on an 11-Point Scale Secondary · Day 0

The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).

Group	Value	95% CI
VOLBELLA® With Lidocaine	9.8	± 0.0

Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) Secondary · Day 0, Day 14, Month 1, Month 6, Month 9, Month 12

The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.

Day 0 Very Well Improved Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	45

Day 0 Very Well Improved Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	43

Day 0 Well Improved Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	34

Day 0 Well Improved Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	37

Day 14 Very Well Improved Right Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	68

Day 14 Very Well Improved Left Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	63

Day 14 Well Improved Right Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	27

Day 14 Well Improved Left Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	30

Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) Secondary · Day 0, Day 14, Month 1, Month 6, Month 9, Month 12

The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.

Day 0 Very Well Improved Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	21

Day 0 Very Well Improved Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	18

Day 0 Well Improved Right Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	38

Day 0 Well Improved Left Side

Group	Value	95% CI
VOLBELLA® With Lidocaine	36

Day 14 Very Well Improved Right Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	43

Day 14 Very Well Improved Left Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	40

Day 14 Well Improved Right Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	35

Day 14 Well Improved Left Side (N=60)

Group	Value	95% CI
VOLBELLA® With Lidocaine	38

Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ) Secondary · Day 0, Day 14, Month 1, Month 6, Month 9, Month 12

Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject's overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).

Day 0

Group	Value	95% CI
VOLBELLA® With Lidocaine	19.3	± 7.1

Day 14

Group	Value	95% CI
VOLBELLA® With Lidocaine	7.4	± 6.4

Month 1

Group	Value	95% CI
VOLBELLA® With Lidocaine	6.0	± 7.2

Month 6

Group	Value	95% CI
VOLBELLA® With Lidocaine	9.5	± 7.7

Month 9

Group	Value	95% CI
VOLBELLA® With Lidocaine	9.9	± 7.9

Month 12

Group	Value	95% CI
VOLBELLA® With Lidocaine	10.7	± 8.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. ). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VOLBELLA® With Lidocaine

Serious: 1/80 (1%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	VOLBELLA® With Lidocaine
Uterine Leiomyoma	Reproductive system and breast disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	VOLBELLA® With Lidocaine
Injection Site Bruising	General disorders	—
Injection Site Erythema	General disorders	—
Injection Site Reaction	General disorders	—
Injection Site Oedema	General disorders	—
Injection Site Pain	General disorders	—
Headache	Nervous system disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Uterine Leiomyoma.

Data from ClinicalTrials.gov NCT02176421 adverse events section.

Sponsor's own description

A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Allergan trials

Trials by the same sponsor.

NCT04609020 — Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment · Phase 4 · completed
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NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
NCT05088980 — Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbita · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02176421 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 16 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02176421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing